510(k) · Cleared
ClearedCardiosoft/Case Cardiac Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DQK Computer, Diagnostic, Programmable
Cleared on Aug 1, 2003 as substantially equivalent to K991014 (General Electric Medical Systems Information Techn, 1999) and 3 other predicates after a 74-day review. Its family tree reaches back 4 generations to 1991. 30 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K903644 (1991). 7 ancestors in all. 30 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 3 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 2 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 1 generation backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- This deviceK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- Descendant · cites it directly · 18 of its ownK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK102854 PC ECGEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
- Descendant · 3 generations on · 11 of its ownK152427 PC ECGEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 10 of its ownK093869 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009 · cites it directly18descendants
- K102854PC ECGEdan Instruments, Inc. · 2010 · cites it directly13descendants
- K131819PC ECGEdan Instruments, Inc. · 2013 · 2 generations on12descendants
- K152427PC ECGEdan Instruments, Inc. · 2016 · 3 generations on11descendants
- K093869SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −3 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −2 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −1 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| 0 (this device) | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| +1 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| +1 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
| +2 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| +3 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| +2 | K093869 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991014 | Case 8000 Exercise Testing SystemSummary page 1…1 CFR 870.1025 Detector and Alarm, Arrhythmia Predicate Devices: CASE 8000 exercise testing system K99 1014 CardioSoft CardioSys K951130… | 1999 |
| * | K951130 | Cardiosoft/CardiosysSummary page 1…CASE 8000 exercise testing system K99 1014 CardioSoft CardioSys K951130 Twave Alternans KO23380… | 1996 |
| * | K023380 | T-Wave Altermans (Twa) Algorithm Option | 2002 |
| * | K002209 | GE Marquette Ecg Analysis Program | 2000 |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K092010 (Edan Instruments, Inc., 2009) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K991014.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
CardioSoNCASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoWCASE Cardiac Testing System is designed to acquire process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data kom ancillary devices (such as Spirometry and Ambulatory Blood…
Read the full statement (296 words)
CardioSoNCASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoWCASE Cardiac Testing System is designed to acquire process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data kom ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CardioSoWCASE Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
CardioSofKASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergometer) and communicates with centralized electronic/digital storage system via network. CardioSofdCASE Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.
CardioSofVCASE Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.
CardioSoWCASE Cardiac Testing System is intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.
CardioSoNCASE Cardiac Testing System offers no diagnostic opinion to the user. Instead it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders hisher own medical opinion.
CardioSoNCASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoWCASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031561: Cardiosoft/Case Cardiac Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031561
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026